Device for folding flexible intraocular implants

ABSTRACT

The invention relates to a folding device for folding intraocular implants having flexible optical portions. Said device comprises two folding element facing each other and whose ends are connected together by deformable means. Each folding element comprises a body and a jaw projecting from said body, an elastically deformable support projecting from said body in the direction in which the two elements are brought together, a positioning stud projecting from said second end of the support perpendicularly to said support and facing upwards so as to co-operate, at rest, with the periphery of the optical portion of the implant, and an extension projecting from said body in the direction in which the two elements are brought together, and having a ramp suitable for co-operating with the support on the other folding element while the two folding elements are being brought together to cause said positioning stud to be lowered.

This is a U.S. national stage of application No. PCT/FR02/04081, filedon 28 Nov. 2002. Priority is claimed on that application and on thefollowing application: Country: France, Application No.: 0115491, Filed:30 Nov. 2001.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a device for folding a flexibleintraocular implant of which at least an optical portion is made of aflexible material.

More precisely, the invention relates to a device of the pincer typethat enables the optical portion of an intraocular implant to be foldedautomatically, the optical portion being made of a biocompatibleflexible material such as a material selected from silicones,hydrophobic acrylics, and hydrophilic acrylics (poly-hydroxyethylmethacrylates (pHEMAs)).

2. Discussion of Related Art

It is known that one of the main advantages of making the opticalportion of an intraocular implant out of a flexible material is that itis then possible for said optical portion (which is usually circular orsubstantially circular) to be folded about a diameter before theresulting folded implant is inserted inside the eye so as to be put inplace on the desired internal portion of the eye. It can be understoodthat, since the optical portion, which can have a diameter of about 6millimeters (mm) is folded before it is inserted in the eye, theincision that needs to be made in the cornea in order to put the implantin place in this way can be of small size, typically about 3 mm to 4 mm.This situation is particularly advantageous because it is known that,when the incision to be made in the cornea is small in size, theincision heals under good conditions, thereby making it possible toreduce the period of convalescence very significantly.

Naturally, since the implant is transparent and since it is relativelysmall in size because the diameter of the optical portion is usuallyabout 6 mm, it can be understood that it is relatively difficult to foldsaid optical portion using conventional surgical instruments. Therefore,mechanical devices have been designed that are capable of performingsuch folding automatically.

Folding devices are of two types. In a first type, the folding device isin the form of a sort of pair of pincers that has two jaws between whichthe optical portion of the implant to be folded is placed. Bringing thetwo jaws towards each other causes the optical portion to be folded, andthe surgeon then merely has to take hold of the folded optical portionwith suitable forceps.

The second type of folding device can be referred to as an “implantinjector” and makes it possible, in a first stage, for the opticalportion of the implant to be folded automatically, and in a secondstage, for the folded implant to be inserted into the eye by means of ahollow needle with a piston for pushing the folded implant into theneedle, it being possible to insert the needle into the incision made inthe cornea.

The present invention relates to the first type of implant-foldingdevice, i.e. to the pincer type.

Numerous implant-folding devices of the pincer type, i.e. of theabove-described type, are already known. Unfortunately, such knowndevices suffer from the drawbacks of not usually enabling the opticalportion of the implant to be held correctly during the foldingoperation, and of not enabling the optical portion to be angularlypositioned relative to the folding system.

OBJECTS AND SUMMARY OF THE INVENTION

An object of the present invention is to provide a folding device thatensures that the optical portion of the implant is positioned correctlyduring the folding operation.

In order to achieve this object, according to the invention, the foldingdevice for folding an intraocular implant of which at least the opticalportion is made of a flexible material comprises two folding elementsfacing each other and whose ends are connected together by deformablemeans making it possible for the two folding elements to be broughttowards each other manually, each folding element comprising a body anda jaw projecting from said body and suitable for receiving a portion ofthe periphery of said optical portion and for supporting said implant.The device is characterized in that each folding element furthercomprises:

an elastically deformable support projecting from said body in thedirection in which the two elements are brought together, and having afirst end secured to the body and a second end;

a positioning stud projecting from said second end of the supportperpendicularly to said support and facing upwards so as to co-operate,at rest, with the periphery of the optical portion of the implant; and

an extension projecting from said body in the direction in which the twoelements are brought together, and having ramp-forming means suitablefor co-operating with the support on the other folding element while thetwo folding elements are being brought together to cause saidpositioning stud to be lowered relative to the plane defined by the twojaws by means of said support deforming elastically.

It can be understood that, by means of the presence of the twopositioning studs, it is possible for the periphery of the flexibleoptical portion of the implant to be positioned correctly and heldcorrectly during the folding operation. Furthermore, by means of thepositioning studs retracting automatically and progressively while thetwo jaws of the folding device are being brought towards each other,said positioning studs do not interfere with operation of the device,and thus do not impede proper folding.

In an improved embodiment of the implant folding device, said foldingdevice further comprises:

an additional elastically deformable support projecting from the body ofone of the folding elements and having, at its free end, a guide memberfor guiding the folding direction, said member projecting upwardsrelative to said additional support and, at rest, being disposed belowthe plane defined by said jaws; and

an additional extension projecting from the body of the other foldingelement and having first ramp-forming means and second ramp-formingmeans suitable for co-operating successively with said additionalsupport so as firstly to cause the implant folding direction guidemember to rise between said jaws above the plane defined by said jaws,and then to cause said folding direction guide member to return to itsinitial position.

It can be understood that this improved embodiment of the folding devicemakes it possible to define the direction in which the implant isfolded, i.e. to force said implant to fold “upwards” when the device isin the normal in-use position. The folding direction guide memberprogressively rising along a diametral direction of the optical portioninitially imparts the direction in which the optical portion folds andthus the direction of the folding that is ultimately obtained. Inaddition, because of the presence of the two ramps, the foldingdirection guide member retracts gradually after the folding directionhas been imparted so that the presence of said guide member does preventthe optical portion of the implant from folding fully.

BRIEF DESCRIPTION OF THE DRAWINGS

Other characteristics and advantages of the invention will appear moreclearly on reading the following description of embodiments of theinvention given by way of non-limiting example. The description refersto the accompanying drawings, in which:

FIG. 1 is a perspective view of one folding element in a firstembodiment of the folding device;

FIG. 2 shows the two folding elements as assembled together in the firstembodiment;

FIG. 3 is a view in section on the plane III—III of FIG. 2, showing howthe positioning stud co-operates with the ramp to cause said ramp to belowered;

FIG. 4A is an overall view in vertical section, showing the entirefolding device in an improved embodiment; and

FIG. 4B is a plan view of the folding device shown in FIG. 4A.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

A first embodiment of the implant-folding device of the pincer type isdescribed below with reference firstly to FIGS. 1 to 3.

As shown more clearly in FIG. 2, the folding device is made up of twofolding elements respectively referenced 10 and 12 and which areidentical in the first embodiment. Therefore, only the folding element10 shown in FIG. 1 is described in detail below.

The folding element 10 has a central body 14 that is relatively bulkyand relatively non-deformable. The body 14 is extended at each of itsends by wings 16 and 18 that are elastically deformable. The wings 16and 18 are terminated by lugs 20 and by complementary bearing surfaces22 making it possible for the two folding elements 10 and 12 to besecured together, at least temporarily.

In its midplane P, P′, the body 14 has a jaw 24 that projects from theinside face 14 a of the body. The jaw 24 is constituted by an implantsupport element 26 for supporting the implant, and by a top extension28, the support element 26 and the top extension 28 defining asubstantially dovetail shaped profile in which a portion of theperiphery of the optical portion of the implant to be folded can beengaged. On one side of the jaw 24 a second extension 30 projects fromthe face 14 a of the body 14, which extension is substantiallynon-deformable. A side portion 32 of the extension 30 defines a guideramp 34 facing downwards and which slopes downwards going towards theface 14 a of the body 14. On the other side of the jaw 24, a thirdextension 36 is provided that also projects from the face 14 a of thebody 14 and that constitutes an arm that is elastically deformablerelative to the body 14. In the vicinity of its free end 36 a, the arm36 is provided with a portion 37 for co-operating with the ramp 34 onthe other folding element. The arm 36 is also provided with apositioning stud 38 that extends upwards relative to the folding deviceas in its in-use position, i.e. in its position shown in FIG. 2. Theextension 30, and more precisely its ramp-forming portion 34, and thearm 36 are disposed such that the extension 30 on one folding element isdisposed facing the arm 36 on the other folding element so that, whenthe bodies 14 of the two folding elements are caused to move closertogether by elastically deforming the branches 16 and 18, the ramp 34co-operates with the portion 37 of the arm 36 so as to cause said arm tobe lowered progressively, thus simultaneously causing the positioningstud 38 to be lowered.

As shown more clearly in FIG. 2, in the initial position, the opticalportion A of the implant is properly positioned relative to the foldingdevice by means of the two jaws 24 and by means of the two positioningstuds 38. When the two bodies 14 of the folding elements are broughttowards each other, the resulting bringing together of the jaws 24causes the optical portion of the implant to be folded about itsdiameter that is perpendicular to the direction in which the jaws arebrought together. Simultaneously, the ramps 34 cause the positioningstuds 38 to be lowered, thereby making it possible, by means of thembeing retracted, for the optical portion of the implant to be foldedfully.

On either side of the system constituted by the jaws, by the extension30, and by the arms 36, FIG. 1 also shows resilient clipping tabs 40 and42. The first clipping tab 40 is provided with two clipping catches,respectively referenced 44 and 46, while the clipping element 42 isprovided with a single catch 48. The clipping elements of the twofolding elements as disposed facing each other make it possible todefine a first relative position for the folding elements by means ofthe clipping catches 44 and 48 co-operating. They also make it possibleto define a second relative position for the folding elements by meansof the clipping catches 46 and 48 co-operating. In the second position,the optical portion of the implant has been folded completely. In saidsecond position, the optical portion of the implant can thus be held inthe folded position while the surgeon takes hold of the folded opticalportion of the implant by means of forceps.

As shown more clearly in FIG. 3, the outside face 14 b of the body 14 ofeach of the folding elements has a top portion that forms a sort ofcollar 50, and a main portion 52 set back therefrom and that issubstantially in the shape of a sector of a cylinder. In order to bringthe two folding elements towards each other, the operator places fingerson the surfaces 52 under the collars 50 as indicated by arrows P. It isthus possible manually to cause the two folding elements 10 and 12 tocome towards each other until the optical portion of the implant isfolded.

Naturally, it is necessary for the folding of the optical portion totake place upwards so that the surgeon can take hold of the foldedoptical portion conveniently using forceps. However, it is to be fearedthat, under certain circumstances, folding of the optical portion mighttake place downwards. In order to avoid this risk, in a preferredembodiment of the folding device, said folding device can preferablyinclude a guide member for guiding the direction in which the implant isfolded, which member is shown in FIGS. 4A and 4B.

The direction in which the implant is folded is defined by a guidemember 60 which is substantially V-shaped 62 having one edge 64 in theform of a ridge. The elastically deformable arm 66 extends in themidplane P, P′ of the body 14 of the folding element 10. The length ofthe arm 66 is such that the ridge 64 of the guide member is disposedalong a diameter of the optical portion A when the two folding elementsare in their initial relative position in which the periphery of theoptical portion is engaged in the jaws 24.

Naturally, the guide member 60 faces upwards relative to the in-useposition of the device, and its ridge is disposed under the support 26of the jaws 24. The guide member 60 is extended by a heel 68 whichextends downwards.

The folding element 12 is provided with an extension 70 that projectsfrom the face 14 a of the body 14 of the other folding element 12 and inthe midplane thereof so that, while the two folding elements are beingbrought together, the extension 70 can co-operate with the heel 68 ofthe guide member 60. In the vicinity of its free end 70 a, the top faceof the extension 70 defines a first ramp 72 which slopes upwards fromthe free end 70 a to a ridge 74. That extension 70 has a second ramp 76that slopes downwards from the ridge 74 towards the face 14 a of thebody 14 of the folding element. The ramps 72 and 76 are defined suchthat, in the first portion of the stage during which the two foldingelements are brought together, the ramp 72 causes the ridge 64 of theguide element 60 to be raised progressively. The ridge 64 acts on thebottom face DP of the optical portion A of the implant, thereby forcingit to fold upwards. Once the heel 68 passes beyond the ridge 74separating the ramps 72 and 76, the ramp 76 makes it possible for theguide member 60 to be lowered progressively, so that it returns to itsinitial vertical position. During the second portion of thebringing-together stage, the guide member 60 being lowered enables it tobe retracted, thereby allowing the optical portion of the intraocularimplant to be folded in full.

1. A folding device for folding an intraocular implant of which at leastthe optical portion is made of a flexible material, said folding devicecomprising two folding elements facing each other and whose ends areconnected together by deformable means making it possible for the twofolding elements to be brought towards each other manually, each foldingelement comprising: a body and a jaw projecting from said body forreceiving a portion of the periphery of said optical portion and forsupporting said implant an elastically deformable support projectingfrom said body in the direction in which the two elements are broughttogether, and having a first end secured to the body and a second end; apositioning stud projecting from said second end of the supportperpendicularly to said support and facing upwards so as to co-operate,at rest, with the periphery of the optical portion of the implant; andan extension projecting from said body in the direction in which the twoelements are brought together, and having ramp means for co-operatingwith the support on the other folding element while the two foldingelements are being brought together to cause said positioning stud to belowered relative to the plane defined by the two jaws by means of saidsupport deforming elastically.
 2. A folding device according to claim 1,wherein said supports and said extensions are disposed on either side ofsaid jaws.
 3. A folding device according to claim 1 further comprising:an additional elastically deformable support projecting from the body ofone of the folding elements and having, at its free end, a guide memberfor guiding the folding direction, said member projecting upwardsrelative to said additional support and, at rest, being disposed belowthe plane defined by said jaws; and an additional extension projectingfrom the body of the other folding element and having first ramp meansand second ramp means suitable for co-operating successively with saidadditional support so as firstly to cause the implant folding directionguide member to rise between said jaws above the plane defined by saidjaws, and then to cause said folding direction guide member to return toits initial position.
 4. A folding device according to claim 3, whereinsaid additional support is disposed below the jaw on one of said foldingelements, and the additional extension is disposed below the jaw on theother folding element.
 5. A device according to claim 1 furthercomprising clipping means comprising a first clipping member secured toor integral with one of the folding elements and a second clippingmember secured to or integral with the other folding element, saidclipping members being suitable for defining a first relative positionfor the bodies of the folding elements, in which first position theoptical portion of the implant is held between the jaws without beingfolded, and a second relative position in which said optical portion isfolded.